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Take a look at a selection of our recent media coverage:

‘Radical plans’ for NHS robotic surgery to reduce waiting lists

12th June 2025

Half a million operations a year will be supported by robotic surgery by 2035 as part of ‘radical plans’ to reduce waiting lists, NHS England has said.

This marks a significant rise from an estimated 70,000 procedures in 2023/24.

NHS England estimated that within the next decade, nine in 10 keyhole surgeries will involve robotic assistance, up from one in five today.

The new NHS England forecast follows the publication of its first national guidance on how robotic programmes should be delivered.

NHS chief executive Sir Jim Mackey said that expanding the use of ‘new and exciting tech such as robotic surgery’ would play a crucial role in reducing elective waiting times.

‘Not only does it speed up the number of procedures the NHS can do, but it also means better outcomes, a faster recovery and shorter hospital stays for patients,’ he said.

Better outcomes, quicker discharge

Compared to traditional keyhole methods, robotic surgery allows greater dexterity, with instruments controlled remotely by a surgeon using a console and 3D camera. In orthopaedic procedures, robots can be programmed to carry out parts of the operation, increasing precision.

Patients undergoing surgery involving robots are able to recover quicker and be discharged sooner, with some bladder cancer patients discharged within five days – half the typical time for traditional open surgery.

Over the past decade, the use of robotics in surgery has expanded. In 2011/12, urological cancer surgery accounted for 80% of robotic procedures but by 2023/24, this fell to 44% even though the number of operations had increased. This is due to significant growth in areas such as colorectal, gynaecology, ENT, and orthopaedic procedures.

Some 11 robotic systems have received conditional approval from NICE: five for soft tissue procedures such as hernia repairs and tumour or gallbladder removals, and six for orthopaedic surgeries.

Relieving pressure on services

John McGrath, consultant surgeon at North Bristol NHS Trust and chair of the NHSE Steering Committee for Robotic Assisted Surgery, said the technology improved patient care, eased surgical workloads and increased capacity.

‘Faster recovery and shorter hospital stays are not only hugely important benefits for patients undergoing surgery, if used efficiently they can have a positive impact on the rest of the system by relieving pressure on services and therefore helping to reduce waiting times,’ he said.

‘Robot-assisted surgery can also make complex operations less physically demanding for surgeons, with the potential to reduce strain on surgical teams, allowing a greater number of complex surgeries to be carried out each day,’ added Mr McGrath.

A version of this article was originally published by our sister publication Healthcare Leader.

Urgent and Emergency Care Plan promises £450m investment to provide faster care for patients

9th June 2025

The UK Government has pledged nearly £450m in its new Urgent and Emergency Care Plan 2025/26 (UEC plan), to address longstanding pressures across the NHS by reducing hospital admissions and lengthy discharge, tackling ambulance handover delays and eliminating corridor care.

Ahead of the anticipated publication of the new NHS 10-Year Health Plan, the UEC plan emphasises shifting patient care into more appropriate settings. This is part of the commitment to move from hospital to community under the Government’s Plan for Change to rebuild the NHS.

This will include around 40 new same day emergency care and urgent treatment centres, and up to 15 mental health crisis assessment centres, as well as new ambulances.

Urgent and emergency care where patients need it

Launching the plan on 6 June, the Department of Health and Social Care and NHS England said these investments and reforms will result in 800,000 fewer patients each year having to wait more than four hours at emergency departments (EDs), with more receiving urgent treatment in their community.

Announcing the UEC plan, health secretary Wes Streeting said: ‘Far too many patients are ending up in A&E who don’t need or want to be there, because there isn’t anywhere else available. The package of investment and reforms will help the NHS treat more patients in the community, so they don’t end up stuck on trolleys in A&E.

‘Hundreds of new ambulances will help cut the unacceptably long waiting times we’ve seen in recent years. And new centres for patients going through a mental health crisis will provide better care and keep them out of A&E departments, which are not well equipped to care for them.’

Chief executive of NHS Providers, Daniel Elkeles, said ‘there is a lot to like’ in the plan and welcomed its inclusion of ‘so many parts of the system, including primary, community and mental health care, in addition to ambulance and hospital services’.

‘It’s helpful that we’re seeing it in early summer, with time to ensure meaningful measures are in place ahead of the added pressures of winter,’ he said. ‘The extra capital investment for same day emergency care and mental health crisis assessment centres and ambulance services is particularly welcome.’

Shorter waiting times for urgent and emergency care

The plan’s publication follows the finding of the National Centre for Social Research’s British Attitudes Survey, published in April by The King’s Fund and Nuffield Trust, which revealed that 69% of respondents were very or quite dissatisfied with the length of time it took to be seen in A&E.

An Ipsos Mori survey from February also revealed 80% of respondents would avoid attending an A&E because of concerns over lengthy waits on trollies in corridors.

The Government has said the new UEC package ‘will improve patients’ experiences this year’, including ensuring at least 78% of A&E attendees are admitted, transferred or discharged within four hours, up from the current 75%.

The plan also puts a strong emphasis on ending 12-hour waits and corridor care, with the aim that fewer than 10% of patients experience such delays, and on expediting discharge for those medically fit to leave, targeting the nearly 30,000 patients a year who currently stay three weeks beyond their discharge-ready date.

A commitment to publish ED performance data from each individual hospital in England is also promised – something the Royal College of Emergency Medicine’s (RCEM) has been pushing for, and says it welcomes. However, the RCEM has since expressed concerns about ‘the lack of a cast-iron commitment to ending dangerous and demeaning 12-hour waits in Emergency Departments’.

A lack of ambition?

‘We have been awaiting this plan since January, and we are pleased to see its publication as the sooner we get on with addressing the issues which manifest themselves in the corridors and carparks of our A&Es the better’, said RCEM president, Dr Adrian Boyle.

‘However, some parts lack ambition – for example accepting that 10% of people will face A&E waits of more than 12 hours, when no patient should. Also maintaining the four-hour standard at 78% when the stated aim is that 95% of patients should move through the ED within this time – something which hasn’t happened for a decade.’

The Royal College of Physicians (RCP) has long called for an end to corridor care, with president Dr Mumtaz Patel calling for NHS England to publish the data it promised on the prevalence of corridor care ‘as a priority’.

‘It will set a baseline to determine whether measures set out in this plan, such as improving the timeliness of discharge and use of urgent treatment centres, are working,’ he said. ‘Success will depend on long-term investment in staffing, better integration between hospital, community and social care, and a stronger focus on the needs of older patients and those living with frailty.’

Ambulance handover targets

Another of the UEC plan’s headline targets includes reducing ambulance wait times for Category 2 calls by over 14%, meeting a new maximum 45-minute ambulance handover standard. A commitment to roll out almost 500 new ambulances across the country by March 2026 has also been promised.

The plan also mandates closer collaboration with community and ambulance services, with ambulance services set to benefit from expanded access to patient records to reduce handover delays, freeing up capacity and positively impacting hospital admissions.

However, Dr Boyle said the RCEM has ‘concerns about how the maximum 45-minute ambulance handover will be achieved without exposing patients to risk and increasing overcrowding in our departments’.

The RCEM ‘will be pushing to ensure that the new so called “Mental Health A&Es” and new same day emergency care services are co-located with existing Emergency Departments’, he added.

Frontline consequences for urgent and emergency care

Hospital staff will be central to delivering these improvements, with a system-wide expectation of shared leadership and accountability for urgent and emergency care performance.

NHS national director for urgent and emergency care, Sarah-Jane Marsh, said: ‘While the 10 Year Health Plan will set out a longer-term vision to transform urgent and emergency services for the 21st century, there is so much more we could all be doing now.

‘This plan sets out not only what we know is working across the country, but how systems must work together to improve access and quality for the benefit of our patients. In order to support this shift in delivery focus, NHS England will be asking providers and systems to be accountable to their own local boards and populations, creating robust winter plans which will be tested during winter exercises throughout September.’

NHS Providers is optimistic that the plan ‘should result in meaningful progress compared to last winter’.

Building workforce capacity will be key

Despite these reassurances, Dr Simon Walsh, British Medical Association (BMA) consultants committee deputy chair and emergency medicine consultant, said this long-promised plan will leave doctors working in EDs and other acute specialties ‘severely underwhelmed’.

‘There is a clear need to increase capacity within acute hospitals to improve patient flow and shorten waits – but the plan does not set out how acute trusts will improve this,’ said Dr Walsh. ‘In reality, beds need staff, and the lack of any plan to retain doctors and therefore to stop persistent rota gaps is a huge oversight.’

Dr Walsh also criticised the proposed mental health assessment centres provision, adding that the BMA has ‘concerns about separating out mental and physical healthcare when the two are so linked’ and that ‘investment in the community is desperately needed’.

In addition, he called the detail on social care ‘woefully inadequate’, concluding that ‘anyone hoping for a radical plan to fix the crisis engulfing emergency care will be bitterly disappointed’, and ‘staff who are battling against impossible circumstances will not feel assured that this plan will deliver.’

The RCP echoes the concerns over capacity and has urged the Government to ensure ‘ongoing engagement with the royal colleges and specialist societies’ to support the success of the plan. And it highlighted that ‘its success will depend on adequate staffing, additional leadership capacity, and investment in IT systems and estate infrastructure.’

Use of agency staff to be eliminated across NHS, says Government

The Government plans to ‘eliminate’ the use of agency staff across the NHS by the end of this parliament and will consider a new law to enforce this if ‘sufficient progress’ to reduce spending on agency staff is not made by autumn 2025.

In a letter to integrated care boards (ICBs) and Trusts, health secretary Wes Streeting and NHS England chief executive Sir James Mackey said they would be taking ‘decisive action’ to ensure Trusts meet the temporary staffing target set out in the planning guidance. This target was to reduce spending on agency staff by 30% over the next financial year.

However, it added that the aim was to ‘eliminate agency use altogether by the end of this Government’s term of office’, and that the Department of Health and Social Care and NHS England would establish a delivery group to monitor the progress of this.

‘If we do not feel that sufficient progress is being made by the autumn, we will consider what further legislative steps we should take to ensure that use of agency staff is brought to an end,’ the letter said.

They added that so far agency spending in 2025 was down by £1bn compared to 2024, following the crackdown on ‘rip-off’ temporary staffing agencies.

In 2023 to 2024, the NHS spent around £3bn on agency staff, according to the DHSC.

Reducing costs and maintaining a flexible workforce

‘We are clear that there is no room for waste in the NHS and every organisation within the health service must play its part. It is simply not right that the taxpayer should foot the bill for billions of pounds of spend on agency staff,’ the letter said.

‘In most cases, agency margins are an unnecessary cost to the service, when other models allow access to the same flexible workforce.’

Health minister Ashley Dalton said: ‘The taxpayer has been footing the bill for rip-off agencies for too long – while patients have languished on waiting lists and demoralised staff faced years of pay erosion.

‘That’s why we are pledging to eliminate this squander, and through our Plan for Change we are making major progress and seeing a radical reduction in costs.

‘We’re already backing our health workers with above-inflation pay rises and now nearly £1bn is being reinvested back to the frontline, getting patients off waiting lists and putting money back into our workforce’s pocket.’

However, resident doctors in England have begun receiving their ballots for renewed industrial action after the British Medical Association said the Government failed to make an offer which would move them towards pay restoration.

Boost frontline services and help to cut down waiting lists

Further commenting on the plans for agency spending, Elizabeth O’Mahony, chief financial officer at NHS England, added: ‘The NHS is fully committed to making sure that every penny of taxpayers’ money is used wisely to the benefit of patients and the quality of care they receive.

‘Our reforms towards driving down agency spend by nearly £1bn over the past year will boost frontline services and help to cut down waiting lists, while ensuring fairness for our permanent staff.’

Last month, a survey by NHS Providers found that 47% of Trust leaders were scaling back services to deliver on financial plans and 37% said their organisations were cutting clinical posts amid financial pressures, with a further 40% considering this.

Some 94% said the steps needed to deliver financial plans would have a negative impact on staff wellbeing and culture at a time of existing low morale, burnout and vacancies.

Last year, Mr Streeting promised to cut long hospital waiting times back down to the NHS 18-week target via financial incentives and performance league tables, as well as announcing plans for stopping NHS staff resigning and then immediately offering their services back to the health service through a recruitment agency and a ban on NHS Trusts from using agencies to hire temporary entry level workers in band 2 and 3, such as healthcare assistants and domestic support workers.

A version of this article was originally published by our sister publication Healthcare Leader.

Higher infection risk identified in children born to women with obesity

Children born to mothers with a body mass index (BMI) of 35 or over are at an increased risk of being admitted to hospital with an infection, a new study shows.

The findings, published in the journal BMJ Medicine, highlight the importance of women maintaining a healthy body weight before and after pregnancy.

In the Bradford-based study, researchers analysed long-term data from nearly 1,000 children born to mothers with BMI ≥35, recording any infections, including those requiring hospital admission, in the first 15 years of the child’s life.

The rate of admission was 53% higher among children whose mothers had grade 2 or 3 obesity (BMI ≥35) than among those with a mother of healthy weight.

Maternal obesity is on the rise, according to the researchers, with estimates suggesting that nearly one in four mothers will be obese when they give birth by 2030. Since obesity is characterised by chronic inflammation, which can lead to a disordered immune system, as well as changes in gene expression and alterations to the gut microbiome, being overweight has the potential to influence the long-term health of the developing foetus.

Maternal obesity and child infection risk

To understand how maternal weight during pregnancy can affect infection rates amongst children, the researchers analysed data from Born in Bradford – a longitudinal, multi-ethnic research programme tracking the health and family lives of over 600,000 Bradfordians.

Between 2007 and 2011, 9,540 singleton babies were born to 9,037 mothers at Bradford Royal Infirmary. The children were followed from birth to 15 years of age, examining the total number of hospital admissions related to infections at less than one year of age, one to four years and five to 15 years. Infections recorded included those of the upper respiratory tract, lower respiratory tract, skin and soft tissue, genitourinary system, gastrointestinal tract, invasive bacterial infections and multisystem viral infections.

Overall, there were 5,009 hospital admissions for infections between birth and the age of 15, with the highest admission rates for infants under one year.

For children born to mothers of a healthy weight, admission rates for infection were lower than those for children whose mothers had a BMI ≥35, at 39.7 admissions/1,000 person-years compared with 60.7/1,000 person-years, respectively.

After adjusting for potentially influential factors, the children’s infection admission rates were positively associated with the mother’s BMI at birth, across all age groups. However, this was only statistically significant at obesity grades 2-3; these children were 41% more likely to be admitted to hospital for an infection at under one year, and 53% more likely to be admitted for an infection between the ages of five and 15, compared with their counterparts.

The observed associations were slightly stronger in boys than in girls, and in Pakistani women than in white British women. Respiratory, gastrointestinal and multisystem viral infections accounted for most of the excess hospital admissions.

Of other potentially modifiable factors that were assessed, caesarean-section birth accounted for 21% of the association between obesity grades 2-3 and childhood infections during the first five years, and child obesity at age four to five for 26% of the association. Breastfeeding for six or more weeks and excessive pregnancy weight gain were not significantly associated, however.

Additional support for HCPs required

Acknowledging the limitations of this type of observational study, the researchers said: ‘The findings of our study highlight the need for public health campaigns and additional support for healthcare professionals to help women of reproductive age achieve and maintain a healthy body weight.’

They added: ‘Although the results indicated a modest effect of maternal obesity, and only in those with obesity grades 2-3, the potential effect on a large number of children globally is substantial.’

A version of this article was originally published by our sister publication Nursing in Practice.

Aortic stenosis treatment disparities reinforced in new study

Women are less likely than men to receive treatment for aortic stenosis, a new study supported by the British Heart Foundation reveals.

The research showed that after a diagnosis of aortic stenosis, women were 11% less likely to be referred on to secondary care and 39% less likely to have a procedure to replace their aortic valve, when compared to men with the same diagnosis.

People from ethnic minority backgrounds and those living in the most deprived areas were also less likely to receive treatment to replace the damaged valve after diagnosis than other patients.

Researchers from the University of Leicester presented the findings at the 2025 British Cardiovascular Society Conference, highlighting the inequalities in diagnosis, referral and treatment for aortic stenosis across the UK.

Rates of referral and aortic valve interventions for aortic stenosis

Using anonymised GP records from NHS practices in England, the researchers identified 154,223 people aged 18 years and over with a first diagnosis of aortic stenosis between 2000 and 2022. They analysed rates of referral to secondary care and aortic valve interventions alongside data relating to sex, ethnicity and socioeconomic status.

Of the 154,223 patients newly diagnosed with aortic stenosis, half of the patients were women (50.4%), who were typically diagnosed at an older age than men. The majority of patients were White British (92.7%), with the remainder identifying as South Asian (2.7%), Black (1.4%), or of mixed or other ethnicities (1.1%). Patients from ethnic minority groups and those living in the most deprived areas were generally diagnosed at a younger age compared to other groups.

Primary care clinicians made approximately 80% of the diagnoses, and referred 28% of these cases to secondary care, with a median referral time from diagnosis of 17 months.

Women were 11% less likely to be referred to secondary care (HR 0.89; 95% CI 0.88 to 0.91) and 39% less likely to receive an aortic valve intervention than their male counterparts (HR 0.61; 95% CI 0.60 to 0.62).

People living in the most deprived areas were referred less frequently than those living in the least deprived areas (HR 0.93; 95% CI 0.90 to 0.96). When it came to receiving treatment, rates of aortic valve interventions were non-significant for the most deprived group (HR 0.97; 95% CI 0.94 to 1.01), but after additional adjustment for comorbidities, this became significant (HR 0.96 95% CI 0.92, 0.99).

Referral rates were higher among South Asian (HR 1.31; 95% CI 1.24 to 1.38) and Black patients (HR 1.21; 95% CI 1.12 to 1.31), compared to White patients. The researchers said this could reflect referrals for other heart issues not related to aortic stenosis, particularly as people from South Asian (HR 0.73; 95% CI 0.68 to 0.78) and Black (HR 0.52; 95% CI 0.46 to 0.58) backgrounds were less likely to receive treatment for aortic stenosis compared to White patients.

‘The clearest picture yet’

Dr Anvesha Singh, consultant cardiologist and associate professor at the University of Leicester’s Department of Cardiovascular Sciences, who was involved in the research, said: ‘Previous studies have shown lower rates of valve replacement in women, and clinicians had assumed that women were less likely to be diagnosed with aortic stenosis. This analysis using large, real-word data clearly shows that this is not the case, giving us the clearest picture yet of what is happening in day-to-day clinical practice.

‘Our study highlights potential inequities in management and care of this common and serious condition. More research is needed to understand the reasons for this and the true prevalence of aortic stenosis in different groups.’

Noting the disparities revealed in the study, Dr Sonya Babu-Narayan, consultant cardiologist at Royal Brompton and Harefield NHS Foundation Trust and clinical director at the British Heart Foundation, added: ‘We don’t yet have the full picture, but these findings are concerning, and we need more research to understand what is driving the differences seen. This will be crucial to enable action to address any underlying causes are stopping some people from having access to the heart valve treatment and care they need when they need it.’

Our Clinical Excellence in Cardiovascular Care returns on 2 July for a one-day event examining the latest advances in cardiology, including a session on the severe aortic stenosis eight-week fast track pathway from Kerry Pena, lead cardiac valve nurse specialist at Leeds Teaching Hospitals Trust. You can register for free now, and look out for the session on-demand via the Hospital Healthcare Europe website after the event.

At the previous Clinical Excellence in Cardiovascular Care event, a panel discussion on advances in interventional cardiology considered UK trials looking at intervening earlier in aortic stenosis for certain patients, asking the question as to whether even asymptomatic groups should be considered for treatment.

Research published in 2023 highlighted widespread inequalities in the provision of aortic valve replacement for adults with aortic stenosis in England when assessing gender, ethnicity and deprivation-based differences for adults.

CERSI-AI: shaping safe and effective AI in healthcare

As artificial intelligence (AI) transforms the UK healthcare sector, navigating its complex regulatory landscape requires a proactive and collaborative approach. Professor Alastair Denniston introduces CERSI-AI, a new national centre of excellence tasked by the Government with shaping the future of AI and digital health regulation, ensuring innovation delivers real benefits without compromising safety, equity or trust in clinical care.

Artificial intelligence (AI) and digital technologies are poised to transform healthcare across several critical domains. One significant area is the automation of high-volume, repetitive tasks, including activities such as managing waiting lists and supporting screening programmes such as those for detecting cancer or eye disease.

In clinical decision-making, AI tools have the potential to assist clinicians by analysing vast and complex datasets, including medical imaging, laboratory results and patient histories. These tools can provide evidence-based recommendations, help to reduce diagnostic errors and support the personalisation of treatment plans.

Digital health technologies also offer considerable promise in improving healthcare outcomes. Tools such as remote patient monitoring systems and predictive analytics enable more proactive care. They can also help reduce hospital readmissions and support the effective management of chronic conditions.

AI can also play a crucial role in enhancing patient safety. By predicting adverse events, automating the detection of clinical errors and enabling timely interventions, AI systems can serve as an early warning mechanism, for example, by flagging signs of patient deterioration in real time and enabling prompt clinical responses.

Rapid advancement leads to regulatory challenges

The rapid advancement of AI and digital health technologies presents several significant regulatory challenges within clinical practice and patient care. These challenges span many areas, each of which requires careful consideration to ensure safe, effective and equitable implementation.

AI tools must undergo rigorous testing and validation to demonstrate their safety and efficacy in real-world clinical environments. One of the foremost regulatory concerns is the establishment of robust clinical evaluation frameworks that can accurately assess these technologies. Additionally, continuous post-market surveillance is essential to monitor ongoing performance and safety. Particular attention must also be given to adaptive algorithms that evolve, as their dynamic nature poses additional complexities for regulatory oversight.

Successful integration of AI tools into clinical practice depends on their compatibility with existing NHS systems and workflows. Regulatory oversight should ensure interoperability with electronic health records, as well as the usability of these tools to minimise disruption to clinicians’ workflows. Furthermore, human oversight must remain a core component of AI-assisted clinical decision-making to uphold accountability and maintain clinical judgment.

AI systems risk perpetuating or exacerbating health disparities if they are trained on biased or unrepresentative datasets. Regulatory bodies must implement measures to detect and mitigate bias within AI models. This includes ensuring datasets are representative of diverse populations and promoting equitable access to AI-driven healthcare solutions, thereby supporting inclusivity and fairness in clinical outcomes.

Many advanced AI models, particularly those based on deep learning, function as ‘black boxes’, making it difficult for clinicians and regulators to interpret how specific decisions are reached. This lack of transparency raises concerns around accountability in clinical decision-making and may hinder trust among both clinicians and patients. Regulators must determine the appropriate level of explainability required, as well as identify the key stakeholders who need access to such explanations.

Traditional medical device regulations often fall short in capturing the dynamic and adaptive nature of AI technologies. Key challenges include defining appropriate regulatory categories, such as software as a medical device (SaMD) and adapting regulatory processes to accommodate systems that learn and evolve. Additionally, coordination across international regulatory bodies is necessary to facilitate harmonisation and ensure consistency in oversight across borders.

Given that AI systems rely heavily on large volumes of sensitive patient data, ensuring compliance with data protection legislation, including UK GDPR, is of paramount importance. Regulators must address challenges such as maintaining data anonymisation without compromising the utility of data for AI training, preventing data breaches or unauthorised access, and managing cross-border data sharing within international research and development collaborations.

Developing CERSI-AI: the rationale

The Centre of Excellence for Regulatory Science and Innovation in AI and Digital Health (CERSI-AI) is a Government-supported initiative, jointly funded by Innovate UK, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Office for Life Sciences (OLS).

It aims to shape the future of AI and digital health regulation by working across the health and technology ecosystem to address current and emerging challenges. Through scientific methodology, community engagement and a whole-system approach, CERSI-AI will accelerate access to innovative treatments and ensure patients benefit from cutting-edge healthcare technologies.

The University of Birmingham was selected to host CERSI-AI due to its internationally recognised strengths in regulatory science and in the complexities of evaluating, regulating and implementing AI health technologies.

CERSI-AI brings together collaboration with academia, healthcare providers, industry, patients and regulators, both in the UK and internationally, to accelerate the safe and efficient development of AI-driven healthcare innovations. By leveraging the strengths of its founding partners – including leading universities (such as the University of Birmingham and University of York), NHS organisations (University Hospitals Birmingham NHS Foundation Trust and NHS Greater Glasgow and Clyde) and industry (Hardian Health, Newton’s Tree, Romilly Life Sciences and the Association of British HealthTech Industries) – CERSI-AI fosters a coordinated approach to address current regulatory and implementation challenges.

This integrated network enables joint research that balances the need for rapid innovation with essential public health values such as safety, equity and cost-effectiveness. By aligning scientific inquiry with real-world regulatory and clinical needs, CERSI-AI helps to streamline regulatory assessments and informs policy development. These collaborations ensure that promising technologies can reach patients faster, without compromising on safety and equity.

Supporting innovators to navigate the regulatory landscape

CERSI-AI will develop a suite of tools, frameworks and guidance to support innovators in navigating the UK’s regulatory landscape for AI and digital healthcare. These include:

  • A public database of AI as a medical device (AIaMD) and SaMD products with market approval and adverse event reports, that supports transparency and regulatory decision-making
  • A borderline manual to help innovators determine whether their AI health technologies qualify as medical devices
  • A regulatory framework for evaluating frontier technologies such as large language models, ensuring adaptability to emerging innovations
  • A post-market surveillance framework for AIaMD/SaMD, enabling agile safety monitoring and efficient data return
  • Guidance on algorithmic performance bias, promoting equity and inclusion in AI systems.

These initiatives are being developed in collaboration with key regulatory and policy bodies, including the MHRA, the National Institute for Health and Care Excellence, the Care Quality Commission, the Department of Health and Social Care, the OLS and the Information Commissioner’s Office.

Supporting clinicians to integrate AI into workflows

CERSI-AI aims to improve the integration of AI tools into NHS workflows by fostering collaboration, standardisation and stakeholder engagement. Through demand-led workshops, webinars and stakeholder surveys, CERSI-AI identifies real-world clinical needs and barriers to adoption. These insights inform the development of practical guidance and standards that align with NHS priorities. Pilot testing of new standards in NHS settings also supports the real-world validation and refinement of these standards.

For clinicians to effectively adopt and utilise AI tools within the NHS, a range of targeted support measures is essential. Comprehensive training and education are needed to ensure healthcare professionals understand both the capabilities and the limitations of AI technologies. This foundational knowledge is crucial for fostering informed and confident use in clinical settings.

Clear regulatory guidance is required. Such guidance helps to build trust and confidence in AI tools, particularly those used for clinical decision support. When clinicians are assured that these technologies meet rigorous standards, they are more likely to engage with them as reliable aids in patient care.

Furthermore, the design of AI systems must be centred on the needs of users. The tools should be intuitive and seamlessly integrate into existing clinical workflows, enhancing care delivery rather than disrupting it. Poorly designed interfaces or overly complex systems risk becoming a barrier rather than a benefit.

Additionally, the development and communication of target product profiles are crucial. These profiles allow the NHS to articulate its priorities and signal demand to industry innovators. By aligning product development with the needs of both patients and the health service, AI tools can be designed to deliver real value and support strategic healthcare goals.

Together, these elements form a comprehensive framework for supporting clinicians as they integrate AI into their everyday NHS practice.

Balancing the needs of innovators, clinicians and patients

CERSI-AI will balance the needs of innovators, clinicians and patients by adopting a regulatory science approach that ensures innovation is evidence-based and shown to be both safe and impactful. This means:

  • Empowering innovators by streamlining regulatory processes and providing clear, evidence-based guidance to accelerate development
  • Prioritising patient safety and outcomes by embedding the patient voice in stages of innovation, ensuring technologies are aligned with real-world needs
  • Supporting clinicians by ensuring AI tools are clinically relevant, easy to use and integrated into existing NHS workflows
  • Facilitating collaboration between innovators, clinicians, patients and regulators to co-design solutions that are both innovative and practical.

By acting as a trusted intermediary, CERSI-AI will ensure that innovation serves both the health of patients and the operational needs of the healthcare system.

CERSI-AI: a leader in AI regulation for healthcare

A key aim for CERSI-AI is to position the UK as a global leader in AI regulation for healthcare by combining scientific excellence, international collaboration and proactive policy engagement.

It will play a pivotal role in advancing regulatory science for AI by leveraging its extensive global network. This includes strategic partnerships with international regulators such as the US Food and Drug Administration, Health Canada, Singapore’s Ministry of Health and Australia’s Department of Health. Through these collaborations, we aim to co-develop regulatory approaches that address shared challenges and establish international benchmarks for best practice.

CERSI-AI will generate cutting-edge, evidence-based insights through collaborative research initiatives. These insights will not only inform the evolution of UK regulatory frameworks but also contribute to the global conversation on safe and effective AI governance in healthcare.

Central to its mission is a commitment to knowledge sharing. Insights derived from UK-led projects will be disseminated internationally, while the Centre will also actively learn from global best practices. Ongoing engagement with UK policymakers and key stakeholders will ensure that regulatory innovation remains aligned with national healthcare priorities and is responsive to real-world needs.

Finally, CERSI-AI will position the UK as a leading testbed for responsible AI innovation by fostering an environment where such tools can be developed, evaluated and deployed at scale.

Supporting the future through CERSI-AI

CERSI-AI will play a pivotal role in ensuring AI technologies are safe, effective and equitably deployed in healthcare. This includes developing robust frameworks and standards to rigorously assess AI tools for safety, performance and fairness before and after deployment.

Clinicians and patients will be actively involved in evaluating these tools, ensuring they are usable, trustworthy and meet real-world clinical needs. CERSI-AI will also support innovators in navigating regulatory pathways, helping beneficial technologies reach patients more quickly without compromising safety.

To ensure ongoing oversight, the Centre will establish systems for post-market surveillance and continuous learning, allowing regulations to adapt as technologies evolve. Crucially, CERSI-AI will champion equity by addressing algorithmic bias and ensuring AI works effectively across diverse populations and healthcare settings.

Through this integrated approach, CERSI-AI will help establish the UK not only as a hub for innovation but also as a global standard-setter in AI regulation for healthcare.

Author

Alastair Denniston MA MRCP FRCOphth PhD

Executive director of CERSI-AI, professor of regulatory science and innovation, University of Birmingham, and honorary consultant ophthalmologist at University Hospitals Birmingham NHS Foundation Trust

Gut biomarkers identified to improve detection and targeted treatment of GI disorders

5th June 2025

Certain gastrointestinal disorders share microbial biomarkers, a study finds, with researchers predicting the discovery could lead to new diagnostic tools to aid early detection.

Gastrointestinal disorders affected nearly 40% of the global population, with gut microbiome-metabolome interactions known to play a crucial role in gastric cancer, colorectal cancer and inflammatory bowel disease (IBD), researchers wrote in the Journal of Translational Medicine.

In this latest study, they aimed to investigate how microbial and metabolic alterations contributed to disease development and test whether biomarkers identified in one disease could be used to predict others.

The research team from the University of Birmingham Dubai, and the UK’s University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, used advanced machine learning algorithms to analyse microbiome and metabolome datasets from patients with gastric cancer, colorectal cancer and IBD as well as healthy controls.

With the complexity of microbiome-metabolite interactions and their critical role in gastrointestinal disorders, it had become more beneficial to train machine learning models to produce highly accurate, reproducible and interpretable insights from large and complex datasets, the researchers wrote.

Their analysis suggested that differential microbes and metabolites associated with gastric cancer could also serve as potential biomarkers for predicting IBD.

‘Interestingly, when we examined the microbes and metabolites linked to [colorectal cancer], we found that they had a stronger predictive performance for [gastric cancer] than for IBD,’ they added.

‘These observations point to the possibility of overlapping disease pathways and biological mechanisms, supporting the idea that microbes and metabolites from one [gastrointestinal disorders] can be used to predict another.’

Identifying microbial biomarkers

For colorectal cancer, microbes identified were predominantly from the phylum Firmicutes, followed by Bacteroidetes, Fusobacteriota, Actinobacteriota and Deinococcota, with significant metabolites shown to include isoleucine and nicotinamide.

At the phylum level, most of the microbes identified in IBD belonged to Firmicutes and Actinobacteriota, with metabolites including urobilin and glycerate also shown to be important.

For gastric cancer, bacteria from the Firmicutes, Bacteroidetes and Actinobacteria groups were common, with changes noted in certain metabolites including dihydrouracil and taurine.

To further validate the findings, researchers cross-referenced the identified microbes and metabolites with existing literature which reinforced that idea that different gastrointestinal disorders share certain biomarkers.

The research team also simulated gut microbial growth and metabolite fluxes, revealing significant metabolic differences between healthy and diseased states.

Biomarkers for early identification and personalised treatment

Co-author Dr Animesh Acharjee, assistant professor of integrative analytics and AI at the Department of Cancer and Genomic Sciences at the University of Birmingham Dubai, said current diagnostic methods such as endoscopy and biopsies were effective but could be invasive, expensive and sometimes missed early-stage disease.

‘Our analysis offers a better understanding of the underlying mechanisms driving disease progression and identifies key biomarkers for targeted therapies,’ he said.

‘These biomarkers could help identify diseases earlier and more accurately, leading to better, more personalised treatment.’

Dr Acharjee said the study’s cross-disease analysis showed the potential of using microbial and metabolic biomarkers identified in one gastrointestinal disorder to predict another.

‘This innovative approach could lead to the development of universal diagnostic tools to revolutionise the diagnosis and treatment of for multiple gastrointestinal conditions,’ he said.

Researchers planned to further explore the clinical applications of their findings and validate the models in larger and more diverse patient cohorts.

Previous research

The study followed recent observational research showing how the microbes of patients with coeliac disease varied from healthy controls and also how the microbiome changed after a year on a gluten-free diet.

The difficulties of detecting colorectal cancer at an early stage have also been highlighted recently, with researchers finding people with chronic conditions were more inclined to attribute bowel habit changes to medication side effects rather than suspecting cancer.

Although screening practices and early diagnosis have improved, many colorectal cancer cases are diagnosed at an advanced stage, highlighting that symptoms can be challenging to recognise and a need for strategies for earlier diagnosis.

Helping breast cancer patients get the right support, at the right time

For cancer patients, having access to trusted information when they need it, in a format that’s right for them, is invaluable. Patient support groups and charities can offer just that, and referral routes to services such as Breast Cancer Now’s ‘Here For You’ gives clinicians the opportunity to signpost patients to this ongoing support outside of the clinical setting, as Heather Pollard, the charity’s head of personalised support, explains.

It’s widely understood that not all breast cancer patients are aware of the support and information that’s available to them outside of their immediate clinical setting.

Some 70% of patients surveyed by Breast Cancer Now said they wanted to speak to an organisation for emotional support and information, and 52% wanted this to happen at diagnosis. A further 22% of patients reported not feeling confident to ask for information as the main barrier to accessing support.

However, 59% of patients surveyed were not offered information on support services at all, and over 80% of those said they would have accessed these services had they been aware of them.

The proportion of patients who say they needed information, support or advice but didn’t get what they needed has been found to increase in the period after treatment when returning to normality and maintaining quality of life and wellbeing are priorities. But the Big Breast Cancer Survey in 2024 showed that wellbeing is in fact a key challenge at all stages of people’s experience with breast cancer.

Breast cancer can be an isolating and anxious experience from diagnosis to treatment and beyond, and charity support services can help address concerns and provide connection to peers.

This can be of particular importance to patients with a diagnosis of secondary breast cancer, and early insight from Breast Cancer Now’s inclusion work shows that this can also be felt acutely by people who are already marginalised by their age, location or ethnicity.

For these patients, isolation can be greater, and more specific information and support can be required. This could be by enabling women to meet others of a similar age or background or using interpreters to enable full understanding of what support is available, for example.

Patient referral routes to ongoing breast cancer support

Breast Cancer Now’s direct referral route for breast cancer patients gives healthcare professionals the opportunity to refer their patients at any stage of their cancer journey, ensuring the provision of ongoing personalised support and information that can complement and enhance that provided by their clinicians.

Here For You is co-designed and co-developed by a lived experience project group, who inform its direction and development. The group inform Breast Cancer Now’s resources, recruitment and strategic direction, meeting monthly with staff members to share their insights.

The referral route was first piloted with four hospitals in 2019 and, following this success, has now seen 70 hospitals signing up and referring over 160 patients per month.

Any healthcare professional can complete a simple referral form for their patient, who will then receive a phone call to discuss their individual needs and how Breast Cancer Now can support them. Patients are offered further follow-up calls after three and six months to ensure that their needs continue to be met.

Patients can be signposted to as many of the charity’s services as required, from the clinically-staffed helpline, peer support service and events – for which there is an access fund for those who may find getting to in-person events difficult – to courses on moving forwards after a diagnosis and more specialised services on topics such as living with secondary breast cancer.

Services are offered in person, by email and online, and interpreters are available for all phone calls to meet language requirements as needed.

Healthcare professional feedback

Results from Breast Cancer Now’s healthcare professional survey, published in the Here For You annual report, showed that the referral route streamlines the signposting of patients to additional support. Some 95% of healthcare professionals said that Here for You means patients access more accurate information on support, and is easy for them to remember rather than juggling details on multiple different services.

All of the healthcare professionals surveyed felt that referral was simple and 98% trusted that the service offers patients the most appropriate support.

One healthcare professional commented: ‘Being a fairly new post, I am not aware of all the services on offer to patients, so I feel my lack of knowledge is supported by Here For You and I feel confident that my patients are being fully supported by the service and not missing out due to my lack of knowledge.’

Breast Cancer Now’s evaluation data shows that 96% of patients would recommend that their healthcare professionals refer other patients to Here for You as they have valued access to the support, information and the approach taken.

Discover the expert line up for Clinical Excellence in Cardiovascular Care and register now

4th June 2025

Hospital Healthcare Europe’s Clinical Excellence in Cardiovascular Care returns this summer for a one-day event examining the latest advances in cardiology – and registration is now open.

Taking place on 2 July, this event brings together renowned experts from recognised Centres of Excellence and other UK hospitals to share their experiences of clinical innovations, examples of best practice and how they are improving patient care.

This time, topics on the agenda include the power of artificial intelligence in atrial fibrillation diagnosis from Professor Chris Gale, professor of cardiovascular medicine and honorary consultant cardiologist at Leeds Teaching Hospitals NHS Trust, as well as approaches for advanced therapies in cardiovascular disease treatments from Andrew Barker, head of the centre for cardiovascular science and Gustav Born chair of vascular biology at the University of Edinburgh.

Dr Gamith Adasuriya, cardiology specialist registrar and operations lead and clinical safety officer at Mara Health, will share his take on whether the remote monitoring of cardiac arrhythmias using wearable digital technology is a paradigm shift or pipe dream.

Kerry Pena, lead cardiac valve nurse specialist at Leeds Teaching Hospitals Trust, will discuss the severe aortic stenosis eight-week fast track pathway, while Dr Alexander Lyon, consultant cardiologist, clinical lead for cardio-oncology service and director of the Cardio-Oncology Centre of Excellence at Royal Brompton Hospital will round off the day discussing the crucial bridge between cardiology and oncology.

What to expect from the Clinical Excellence in Cardiovascular Care event

This year’s summer cardiovascular care offering has been developed by the team at Hospital Healthcare Europe and Hospital Pharmacy Europe with guidance from industry experts.

The event is free to attend and comprises individual presentations and sponsored sessions delivered virtually live and on-demand, all tailored to provide maximum convenience and work around your busy schedule.

Select sessions most relevant to your clinical practice, specifically tailoring the day to your needs, and gain CPD hours from the comfort of your computer.

With a whole host of fascinating insights and inspiration for improving patient care, it’s not to be missed. Register now to join us for Clinical Excellence in Cardiovascular Care on 2 July and on demand in Hospital Healthcare Europe’s Clinical Excellence Catch-up zone.

Read and watch Clinical Excellence content

You can watch a selection of previous Clinical Excellent event sessions in the Catch-up zone now, as well as being able to access a whole host of additional long-reads and interviews with prominent clinicians from Centres of Excellence and beyond in the Cardiovascular zone – look out for the orange Clinical Excellence tag.

This content includes a recording of a panel discussion on managing pulmonary hypertension as an MDT and a Royal Papworth Hospital case study on improving the flow and experience of cardiac surgical patients via the hospital’s new Enhanced Recovery Unit.

A two-part series rounding up a panel discussion on advances in interventional cardiology from the previous Clinical Excellence in Cardiovascular Care event is also now available, with insight into treating chronic coronary disease and acute coronary disease.

The autumn schedule for Clinical Excellence will be announced soon, so watch this space.

Advances in interventional cardiology part two: Impella and TAVI for acute disease

Speaking at Hospital Healthcare Europe’s Clinical Excellence in Cardiovascular Care event, our panel of interventional cardiology specialists, including Drs Alex Zaphiriou and Sundeep Kalra and Pierluigi Costanzo, shared ideas and insights into the progress of techniques, procedures and devices for acute coronary disease, including Impella and TAVI. They continued their discussion about their evolving approaches to patients previously labelled as having no hope, the importance of multidisciplinary working, the trials set to transform clinical practice and lessons to be learnt from Europe and beyond.

Significant advances in interventional cardiology techniques and procedures have seen the likes of coronary sinus reducers and new techniques for revascularisation in advanced disease helping to manage symptoms in chronic coronary disease, as discussed in part one of this panel discussion. But what about in acute disease?

This question was put to our three Clinical Excellence event panellists by session chair Dr Brian Halliday, consultant cardiologist and clinical lecturer in cardiomyopathy, at the Royal Brompton and Harefield Hospitals and the National Heart and Lung Institute in London.

He was joined by Dr Alex Zaphiriou, consultant in interventional cardiology at Queen Elizabeth Hospital, Birmingham; Dr Sundeep Kalra, consultant interventional cardiologist at London’s Royal Free Hospital; and Dr Pierluigi Costanzo, consultant interventional and structural cardiologist and clinical lead for coronary intervention at Royal Papworth Hospital NHS Foundation Trust in Cambridge.

In the last year or so, we’ve seen a randomised trial that was positive in cardiogenic shock with Impella. How has that changed things, and how are we going to need to adapt?

Dr Zaphiriou: I work in a transplant centre, so we’ve been lucky enough to use the Impella technology for the last 12 years. So, what is it? It looks like a pigtail catheter that is implanted through the femoral artery all the way to the left ventricle. A small motor sucks blood from the left ventricle, ejects the blood to the ascending aorta in a non-pulsatile way and provides an extra cardiac output that, realistically, is around 3.5 litres per minute, on top of whatever cardiac output the patient has.

A large bore sheath is required, so there are complications, and the aftercare can be quite challenging. You need to be very familiar with possible complications and how to adjust, position and readjust the device as necessary. Sometimes you need to use echocardiography – either transoesophageal or transthoracic – to find the optimal position in the left ventricle, et cetera. So, it’s not a straightforward technology to use.

Having said all that, we had a positive outcome in a selected group of patients. A Danish study called DanGer Shock examined the impact of Impella in cardiogenic shock due to ST-elevation myocardial infarction (STEMI). They demonstrated, for the first time, a substantial drop in all-cause mortality – something like 58% without Impella to 46% with Impella. It’s a very important message.

I’m very pleased that this is the study outcome, but I’m really curious about how we’re going to implement this in our everyday practice. Do we have dedicated cardiogenic shock centres? How is shock recognised in the community? How do we know that the paramedics should bring a STEMI with shock to, for example, the Queen Elizabeth from another hospital that does STEMI? The logistical challenge to implement the positive findings in our everyday practice is going to be tremendous.

How can we implement the treatment of cardiogenic shock in the context of acute myocardial infarction?

Dr Kalra: DanGer Shock was a really significant trial because lots of people have been using Impella, but without the data to support its use. If we just look at London, there are seven heart attack centres, but not all have access to this device. One of the key things, again, with any advanced level treatment is you need to regionalise this to Centres of Excellence. Every heart attack centre offering every part of cardiogenic shock treatment may not be realistic.

You’ll have the highest level of support available in the transplant centre – in London that’s Harefield – which can offer absolutely everything to a patient. If you’re setting up a network with different levels of cardiogenic shock capability, a key thing to logistically look at is transporting patients between a heart attack centre without advanced cardiogenic shock treatment options and one that can offer it. That offers another big dilemma of how to transport these critically unwell patients.

There has to be a level of education as treatment of cardiogenic shock isn’t standardised. You’re going to get different levels of treatment depending on your postcode and which way your ambulance turns when it picks you up. So, being able to network and get hold of colleagues who are au fait with using Impella and getting patients to the right place at the right time, is absolutely key.

Pierluigi, what’s your take on Impella, and does this signal the end of balloon pumps as a treatment option?

Dr Costanzo: Good old balloon pumps! We use a lot of them and will still use them. I think the Impella will certainly be superior to balloon pumps in a selected population. The DanGer Shock trial has demonstrated a cluster of patients that, if intervened upon early enough, will actually survive. I agree that there is significant benefit mortality-wise, but it’s still 46%.

I had the chance to dig into the details of the trial for prepping a cardiogenic shock programme here at Royal Papworth Hospital and most of the mortality, even with Impella, was related to vascular complications or Impella being inserted when it’s too late.

There is a fairly new classification of cardiogenic shock, provided by the Society of Cardiovascular Intervention in the US, where understanding the level of cardiogenic shock and implanting the Impella early enough will probably lead to better results.

I was lucky enough to do my fellowship years at the Toronto General when the Impella programme was launched, and they did 30 Impellas for cardiogenic shock. The results were not good at all because the perception was that you have to put it in when the patient is in extremis, which is not the case as that’s too late.

We’re actually prepping data from our centre with all the cardiogenic shock presentations from 2015 and we will look at whether there is a cluster of patients that could potentially benefit.

Dr Halliday: Moving on now to the area of valves and minimally invasive valve interventions – an areas that seems to be exploding at the minute. At ESC, there were some transcatheter aortic valve implantation (TAVI) trials, including the first TAVI trial in women showing it’s not a male-specific benefit.

Where do you see TAVI’s current role, where will we end up, and what’s your route for selecting patients?

Dr Zaphiriou: When we first started TAVI, patients were extremely frail or very elderly. It’s been very interesting seeing how the criteria have changed, obviously always supported by data. Now, data are much more favourable in putting patients of intermediate risk forward for TAVI.

I can see that there will be a point where the lowering of the threshold will stop because we should never forget that surgical treatment for aortic heart disease is a very good and established treatment.

It’s crucial that we have a multidisciplinary team (MDT) approach and that we invite the patients to participate in the decision-making. There are positive and negative, no matter which approach we follow, for patients who are suitable for both procedures.

I’m also slightly worried that perhaps newer generations of cardiac surgeons are becoming less keen to take on challenging cases because of the ‘TAVI effect’’ where they have stopped operating on elderly multimorbid patients because there’s another option. But there are cases where surgical intervention is the only option, and we end up with a patient who is not suitable for TAVI and the surgeons won’t take them on.

That’s my area of concern, but otherwise, it’s tremendous to see how the TAVI service has expanded. In my institution, it’s been great to see how much discussion takes place behind the scenes to make sure the patient selection is appropriate.

There are a couple of UK trials looking at intervening earlier in aortic stenosis for certain patients. What’s your current approach to selecting patients, and should we be considering even asymptomatic groups?

Dr Kalra: In terms of treatment for asymptomatic patients, we can extrapolate the prognostic data from the surgical experience. We know that with severe aortic stenosis, there is a prognostic implication for untreated disease, so I’m not too worried about treating asymptomatic patients.

In South London, they’ve changed the funnel referring in severe aortic stenosis and it’s combined now for surgery and for TAVI. It’s an age-based criteria so if you’re over the age of 75 or 80, you go to see a TAVI operator first.

At the age of 80, I think it’s reasonable. We know that it’s a safe device in the right patient, they can be discharged very quickly and it’s got longevity of 10 to 15 years – what more are you looking for in an 80-year-old? Why put them through cardiac surgery?

You can propagate, you can think and talk a lot about patients in MDTs, and should they have surgery, should they have TAVI? But I think we should be looking at how we actually get these patients to the right place and be more prescribed in directing the patients to the correct person.

Are there patients over the age of 70 that you wouldn’t offer TAVI to who are maybe better served by surgery?

Dr Costanzo: That’s a great question and local policies will usually dictate that. But certainly, someone aged between 70 and 75 is a surgical candidate by default and shouldn’t even see the TAVI operator, they should see a surgeon first.

We’re seeing from the US that they’re actually explanting TAVI valves that they put in too early in patients’ 60s, and TAVI valve explanation comes up with mortality risk. We should probably be looking at that if we want to understand our future in terms of lowering the bar for age and learn the lesson that the Americans have already learned.

We’ll finish on treatment of aortic valve regurgitation. Where do you see transcatheter edge-to-edge repair (TEER) of the mitral valve fitting in the management of patients with heart failure?

Dr Zaphiriou: It’s very exciting and very promising. I want to continue the theme of patients who previously had no hope and focus a little bit on tricuspid valve regurgitation. We’ve all come across these patients and sometimes it’s desperately difficult to keep them out of hospital, particularly if they have torrential tricuspid regurgitation, and to offer them a little bit of a quality of life. And I think, apart from edge-to-edge repair for tricuspid valve disease, there is new technology now with TAVI-style implantable valve, which can be safely anchored in the tricuspid valve position. This shift from using technology initially designed to treat multiple regurgitation to treat tricuspid valve regurgitation, and the new dedicated valve for tricuspid valve, gives a lot of hope in patients who are really difficult to treat.

Now, there is not yet solid evidence to suggest that there is tangible prognostic benefit but there are ongoing trials. Anecdotally, a lot of patients who have been done in our centre on compassionate grounds, if you like, have felt much better and the results have been really impressive, but we are desperate for some trial data.

Dr Kalra: If we wait for randomised control trials, we’re going to be a long way off offering these treatments to patients. That’s certainly the gold standard and that’s what we should be aspiring to.

On pragmatic terms, we know regulation can delay the introduction of treatment. If we’ve got the safety data about the actual procedure, it’s safe and we can effectively deliver this technology, I think there’s definitely a case to be made for using it on a case-by-case basis. But ideally, you’d want these to be done within the confines of a trial so you can be certain of the treatment strategy you’re offering patients.

Finally, since we’ve been talking about patients without hope, have you used mitral TEER in patients with very advanced heart failure and reduced ejection fraction, who are almost at point of needing transplant, to postpone transplant or as a holding measure?

Dr Costanzo: The short answer is no, although there are some data, such as that TEER for mitral valve in advanced heart failure might be beneficial in postponing the potential heart transplant or requirement of left ventricular assist devices (LVAD).

In actual fact, I find it difficult because once you treat the severe mitral regurgitation in a patient with a very bad ventricle, the ventricle takes a hit with an increased preload, and patients tend to do quite badly. Sometimes you even need mechanical support, and it’s difficult to predict which patient can be delayed for the requirement of LVAD or transplant by doing a TEER.

At least in this centre, we really find it difficult. We’ve done it a couple of times, and we had to insert a mechanical support device afterwards and then wait for a heart for transplant.

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